Kornimate/medical-research-clean huggingface dataset:
a trial evaluating the efficacy of metastasectomy in patients with oligo-metastatic breast cancer(omit)

Conditions: Breast Cancer

Summary: this is a randomized clinical trial (omit study) evaluating the efficacy of metastasectomy in patients with oligo-metastatic breast cancer.


Eligibility criteria:
inclusion criteria: 1. women aged 18-70 years old; 2. ecog score: 0-2 points; 3. the expected life period is more than 3 months; 4. histologically confirmed metastatic breast cancer: locations include central lung lesions, peripheral lung lesions or liver metastases; 5. pet-ct or other imaging showed patients with ≤3 metastastatic sites, involving 1-2 organs mentioned above, single lesion ≤5cm; 6. according to the recist 1.1 edition, there is at least one measurable lesion; 7. the main organs are functioning normally, meeting the following criteria: blood routine: hb \> 90g/l (no blood transfusion within 14 days); anc \> 1.5 x 109/l; plt \> 75 \* 109/l;liver function: total bilirubin tbil is less than 1.5 x uln (upper limit of normal value); alt and ast are less than 3 x uln; if there is liver metastasis, alt and ast are less than 5 x uln;renal function: serum creatinine \< 1 x uln; 8. participants voluntarily joined the study, signed informed consent, and followed up. exclusion criteria: 1. the number of metastastatic sites ≥ 3, or the surgeon determines that the r0 resection cannot be achieved; 2. with metastatic lesions other than liver or lung 3. patients with local recurrence 4. palliative radiation therapy or interventional therapy have been performed previously for metastatic lesions 5. has received systemic treatment for metastatic disease, such as chemotherapy, targeted therapy, endocrine therapy, immunotherapy, etc. 6. pregnant or lactating women, women of childbearing age who cannot practice effective contraceptives; 7. involvement in clinical trials of unlisted drugs within 4 weeks before the start of this study; 8. severe cardiopulmonary insufficiency, severe liver and kidney insufficiency;

Keywords: metastasectomy oligo-metastatic breast cancer
high resolution, 18f-psma pet-mri before prostate cancer hifu or radical prostatectomy

Conditions: Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Disease

Summary: this prospective trial aims to determine if enhanced prostate imaging using two novel imaging technologies (high resolution dwi and 18f-psma pet-mri) will detect prostate cancers not seen on standard multiparametric prostate mri in patients considered candidates for focal hifu.

this is a prospective trial to evaluate the effectiveness of 18f-psma pet-hrmri versus standard mpmri at identifying prostate cancer targets for hifu therapy. participants with clinically localized, unilateral high grade prostate cancer (gleason score 7-10 prostate cancer localized to one lobe on prior biopsies) or at high risk for having unrecognized high grade prostate cancer (overall gleason score 6 with \> half of systematic biopsy cores positive and \> 50% of core involvement in at least one core), interested in hifu would receive both a standard mpmri and 18f-psma pet-hrmri. participants would then undergo a mapping biopsy using a standard sextant template plus mri/us-fusion targeted biopsy of any lesion suspicious lesion on mpmri or pet-hrmri.

Eligibility criteria:
inclusion criteria: 1. biopsy consisting of ≥ 10 tissue cores sampled 2. psa \<20 ng/ml (for hifu arm only) 3. ct1-ct2c 4. either overall gleason score \> 7 with gleason grade 4 or 5 component localized to one lobe (i.e. right or left) or overall gleason score 6 with \> half of systematic biopsy cores positive and \> 50% of core involvement in at least one core (for hifu arm only) 5. patient considering focal hifu therapy or robotic radical prostatectomy exclusion criteria: 1. previous local therapy for prostate cancer 2. inability to receive pet tracer 3. inability to receive mri 4. estimated glomerular filtration rate (gfr) \<15 ml/min/1.73 m2 5. any other condition which, in the investigator's option, may make the patient a poor candidate for participation in a clinical trial.

Keywords: diagnostic imaging high-intensity focused ultrasound hifu 18f-psma high resolution diffusion-weighted imaging
the effect of zoledronic acid on bone loss in prostate cancer patients undergoing androgen deprivation therapy

Conditions: Prostate Cancer

Summary: the purpose of this study is to compare the effect of an investigational drug used intravenously and placebo administered every three months for one year, on bone loss associated with initial androgen deprivation) in men with prostate cancer without metastasis. in order to participate in this trial male patients must be 18 years of age or older and have been diagnosed with prostate cancer without metastasis and within one year of starting their androgen deprivation therapy at the day of randomization onto this trial. in addition, patients who have undergone a recent orchiectomy (or"ke-ek'te-me) (removal of one or two testes) are eligible to participate. patients who received any prior bisphosphonate therapy or prior treatment with systemic corticosteroids within in the past 12 months are not eligible to participate. also patients who are receiving treatment for osteoporosis are not eligible to participate. inclusion into this clinical trial with this investigational drug is based on the protocol entry criteria and evaluation from a participating trial investigator.


Eligibility criteria:
* histologically confirmed diagnosis of carcinoma of the prostate * no distant metastases (stage tnmo) (ie. prostate cancer without metastases) * patients within one year at the day of randomization from initiation of androgen deprivation therapy with a lhrh agonist (with or without an antiandrogen) and with the intended duration of androgen deprivation therapy of at least 12 months. patients may also enter if they have received an orchiectomy (or"ke-ek'te-me) within two weeks of visit 1 * patients who received any prior bisphosphonate therapy in the past 12 months will be excluded * patients who are currently receiving diethylstilbesterol (des) or pc-spes (treatment for osteoporosis) will be excluded * patients who have received prior treatment with systemic corticosteroids within the past 12 months will be excluded (short term corticosteroid therapy, e.g. to prevent/treat chemotherapy-induced nausea/vomiting or for acute illness like asthma exacerbation, is acceptable) * other eligibility criteria may apply

Keywords: prostate cancer bone loss osteoporosis bone mineral density androgen deprivation therapy
prospective quality improvement project for high-risk diabetes patients

Conditions: Diabetes Mellitus; Latent Tuberculosis Infection; Continuous Glucose Monitoring; Quality of Life

Summary: diabetes is the most important comorbidity of tuberculosis patients in taiwan, and 1/4 of tuberculosis patients also it is a diabetic patient, and the treatment of latent tuberculosis infection is currently an important policy of the taiwan disease control agency one, because babies are prone to encounter difficulties in the early stages, because of the spread of australian patients in the community, the department of disease control encourages patients with diabetes to receive screening and treatment for latent tuberculosis infection.

diabetes mellitus is the most prevalent comorbiditiy for patients with active tuberculosis in taiwan. more than one fourth of the patients with incident tuberculosis has diabetes mellitus. the latent tuberculosis infection treatment is recommended by the centers of disease control (cdc) of taiwan to halt the transmission of tuberculosis in the community. considering a relatively long delay in diagnosis of tuberculosis in clinical practice, eliminate the dormant tuberculosis germs a the stage of latent infection is the most cost-effective strategy to avoid tuberculosis transmission. the population with diabetes mellitus and inadequate blood sugar control are at increased risk of latent tuberculosis infection and activation and are encouraged to undergo latent tuberculosis screening and treatment. however, the anti-tuberculosis agents could have significant drug-drug interaction with the drugs used for diabetes mellitus control. the extent of its impact on blood sugar is still unclear. we aim to investigate the fluctuation of blood sugar during latent tuberculosis treatment with continuous subcutaneous sugar monitoring device to evaluate the possible associated risk of hyperglycemia or hypoglycemia to enhance treatment safety. inadequate blood sugar control is the root for immune dysfunction and render the patients vulnerable to infectious diseases. hence, improvement in the blood sugar control not only leads to a better immune function to avoid tuberculosis infection but also reduce the risk of progression for cardiovascular and renal disorder. the present study proposed a protocol of 12-week aggressive blood sugar control and education program using phone call to improve the blood sugar control and life quality. furthermore, to evaluate the efficacy of anti-tuberculosis treatment for latent tuberculosis, we propose to evaluate the mycobacteria-specific antigen immune response by using the interferon-gamma releasing assay before and after anti-tuberculosis treatment.

Eligibility criteria:
inclusion criteria: * diabetic patients had a record of glycated hemoglobin (hba1c%) greater than 9% in the past year. exclusion criteria: * be younger than 20 years old. * unconsciousness or severe dementia, unable to conduct quality of life questionnaire assessment.

Keywords: diabetes mellitus quality of life latent tuberculosis infection continuous glucose monitoring
virtually-integrated co-management between complex care and community-based primary care providers

Conditions: Chronic Illness

Summary: this is a pilot trial to test whether tertiary center-affiliated pediatricians with expertise in medical complexity joining medical visits with patients' community primary care providers is feasible and acceptable. we will also collect data on a range of patient-centered and utilization outcomes to determine effect compared to usual care.


Eligibility criteria:
inclusion criteria: caregiver of patient seen for co-managed care in special care clinic; caregiver has a smartphone that will accept the technology; pcps office has wireless internet connection - exclusion criteria: child is in foster care -
motexafin gadolinium plus radiation therapy in treating children with newly diagnosed brain stem glioma

Conditions: Untreated Childhood Brain Stem Glioma

Summary: radiation therapy uses high-energy x-rays to damage tumor cells. drugs such as motexafin gadolinium may make the tumor cells more sensitive to radiation therapy. phase i trial to study the effectiveness of motexafin gadolinium plus radiation therapy in treating children who have newly diagnosed brain stem glioma

objectives: i. determine the maximum tolerated dose (mtd) and schedule of motexafin gadolinium administered prior to radiotherapy in children with newly diagnosed diffuse intrinsic pontine glioma. ii. determine the toxic effects of this drug given at the mtd in these patients. iii. determine the intratumor and brain distribution of this drug by magnetic resonance imaging (mri) in these patients. outline: this is a dose-escalation study of motexafin gadolinium. approximately 2-5 hours before radiotherapy, patients receive motexafin gadolinium iv over 5 minutes. patients undergo radiotherapy 5 days a week for 6 weeks. cohorts of 3-6 patients receive escalating doses of motexafin gadolinium until the mtd is determined. the first cohort receives motexafin gadolinium 5 days a week for 3 weeks; the second cohort receives motexafin gadolinium 3 days a week for 6 weeks; and subsequent cohorts receive motexafin gadolinium 5 days a week for 6 weeks. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. patients are followed every 3 months for up to 3 years. projected accrual: a maximum of 24 patients will be accrued for this study within 2 years.

Eligibility criteria:
inclusion criteria: * clinically and radiographically (mri) proven newly diagnosed diffuse intrinsic brainstem glioma * greater than 50% intra-axial involvement of the pons, pons and medulla, pons and midbrain, or entire brainstem * contiguous involvement of the thalamus or upper cervical cord allowed * performance status - ecog 0-2 * more than 2 months * absolute neutrophil count at least 1,000/mm\^3 * platelet count at least 100,000/mm\^3 * hemoglobin at least 10.0 g/dl (transfusion allowed) * no glucose 6 phosphate dehydrogenase deficiency * bilirubin no greater than 1.5 times normal * sgot or sgpt less than 1.5 times normal * creatinine no greater than 1.5 times normal * creatinine clearance or radioisotope glomerular filtration rate at least 70 ml/min * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no concurrent immunomodulating agents * no other concurrent chemotherapy * concurrent corticosteroid therapy allowed for increased intracranial pressure only * no prior cranial radiotherapy * no prior motexafin gadolinium * no other concurrent experimental agents
effects of tadalafil once a day for 12 weeks in men with signs and symptoms of benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: the purpose of this study is to evaluate the function of the bladder and urethra during urinary storage or voiding in men with signs and symptoms of benign prostatic hyperplasia treated with either placebo or tadalafil.


Eligibility criteria:
inclusion criteria: * men 40 years of age or older with lower urinary tract symptoms (luts) with a total international prostate symptom score (ipss) greater than or equal to 13 at visit 1. * agree not to use any other approved or experimental medications for benign prostate hyperplasia (bph)-lower urinary tract symptoms, including alpha blockers, 5-alpha reductase inhibitors, pde5 inhibitors, or herbal preparations at any time during the study. * have not taken finasteride or dutasteride therapy for at least 4 months prior to visit 2; have not taken any other luts therapy (including herbal preparations) or pde5 inhibitors for at least 4 weeks prior to visit 2. * have had bph-luts for greater than 6 months prior to visit 1. exclusion criteria: * any pelvic surgical procedure on the urinary tract, including minimally invasive bph-luts therapies and penile implant surgery. * history of urethral obstruction due to stricture, valves, sclerosis, or tumor. * current neurologic disease or condition associated with neurogenic bladder (for example, parkinson's disease, multiple sclerosis). * history of cardiac conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study. * history of angina requiring treatment with nitrates. * prostate specific antigen (psa) greater than 10 nanogram/milliliter (ng/ml) at visit 1.

Keywords: benign prostatic hyperplasia benign prostatic hypertrophy
serum cxcl10 and crp levels in patients with acne vulgaris in correlation with disease severity

Conditions: Acne Vulgaris

Summary: the correlations between cxcl10 levels, crp, and acne severity scores (e.g., global acne grading system) suggest that cxcl10 could serve as a biomarker of inflammation and acne severity. understanding the relationship between cxcl10, crp, and acne severity may offer insights into novel therapeutic strategies targeting inflammatory pathways in acne.

cross-sectional observational study. using 4 groups a 3 of different acne severity and controle one . the serum cxcl10 and crp will measured in each patient to correlate with disease severity

Eligibility criteria:
inclusion criteria: 1. patients aged 12-40 years diagnosed with acne vulgaris. 2. both genders included. 3. patients with mild, moderate, or severe acne severity as determined by a validated scoring system (e.g., global acne grading system). 4. patients not on systemic acne treatment (e.g., isotretinoin or antibiotics) or anti-inflammatory drugs. exclusion criteria: 1. patients with autoimmune diseases, systemic illnesses, acute infection or any other chronic inflammatory conditions that may affect crp or cxcl10 levels. 2. pregnant or lactating individuals.

Keywords: acne vulgaris cxcl10 crp
comparison of oral octreotide capsules to injectable somatostatin analogs in acromegaly

Conditions: Acromegaly

Summary: octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. in a recent phase 3 trial (optmal; nct03252353), oral octreotide capsules demonstrated sustained biochemical response up to 13 months in patients with acromegaly previously managed with somatostatin analog injections (ref). the objective of this study was to compare the efficacy, safety, and patient reported outcomes (pros) between oral octreotide capsules and injectable somatostatin receptor ligands (srls).

this was phase 3, randomized, open-label, active controlled, multicenter study to evaluate the maintenance of response, safety and patient reported outcomes (pros) in acromegaly patients treated with octreotide capsules and in patients treated with standard of care parenteral somatostatin receptor ligands (srls), who previously tolerated and demonstrated biochemical control on both treatments. the core study consisted of three phases: a screening phase, run-in phase and a randomized controlled treatment (rct) phase. eligible patients who were biochemically controlled on parenteral srls were switched to octreotide capsules for a 26-week period run-in phase. during this phase the effective dose for each patient was determined through dose titration. patients whose acromegaly has been controlled biochemically on octreotide capsules at the end of the run-in phase entered a 36-week open-label rct phase, where they randomized to continue on octreotide capsules or switch back to their injectable srl treatment (as received prior to screening). following the completion of the core study (screening, run-in and rct phases), eligible patients were offered to enter the study extension phase and receive octreotide capsules until product marketing or study termination. a sub-study, performed in selected non-european sites, allowed patients with inadequate biochemical control on octreotide capsules during the run-in phase to enter a combination phase and receive co-administration of octreotide capsules with cabergoline tablets for a total of 36 weeks.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of acromegaly * treatment with somatostatin analogs injections (octreotide or lanreotide) for at least 6 months * biochemical control (igf -1 \< 1.3 x uln and gh \< 2.5ng/ml) exclusion criteria: * injections of long-acting somatostatin analogs, at a dosing interval \> 8 weeks. * pituitary radiotherapy within 5 years * pituitary surgery within six months * patients who previously participated in ch-acm-01 study * any clinically significant uncontrolled concomitant disease * symptomatic cholelithiasis * previous treatment with: * pegvisomant, within 12 weeks * dopamine agonists, within 6 weeks * pasireotide, within 12 weeks

Keywords: octreotide capsules acromegaly somatostatin receptor ligands (srls) mpowered ooc-acm-302
physiopathological study of autonomic failure in parkinson's disease

Conditions: Parkinson's Disease

Summary: the aim of the study is to evaluate the autonomic failure in parkinson's disease by clinical, electrophysiological and neuropathological examination.


Eligibility criteria:
inclusion criteria: * patients with parkinson's disease * ages 45 to 80 years, both genders * patients who signed informed consent exclusion criteria: * autonomic function modifying treatment * pre-existing neuropathy or risk factors for neuropathy * dementia * colonic disorders * coagulation disorders (may be due to treatment)

Keywords: autonomic failure, parkinson's disease, electrophysiological assessment, neuropathological assessment
antibody persistence to revaxis or dt polio and immune response to tetravac-acellulaire

Conditions: Diphtheria; Tetanus; Poliomyelitis

Summary: primary objectives * to describe in 11 to 13-year-old children previously vaccinated with either revaxis or dt polio at 6 years of age the antibody persistence against diphtheria, tetanus, and poliovirus types 1, 2 and 3 * to describe one month after a booster dose of tetravac-acellulaire the immune responses against diphtheria, tetanus, and poliovirus types 1, 2 and 3 secondary objectives * to describe other parameters of the antibody persistence against diphtheria, tetanus and poliomyelitis antigens * to describe other parameters of the immune responses to diphtheria, tetanus and poliomyelitis antigens one month after a booster dose of tetravac-acellulaire * to describe the safety profile of a booster dose of tetravac-acellulaire


Eligibility criteria:
inclusion criteria: * healthy child 11 to 13 years of age previously vaccinated in study f05-tdi-301 exclusion criteria: * immunization against diphtheria, tetanus, pertussis and/or poliomyelitis beyond study f05-tdi-301 * previous clinical or bacteriological diagnosis of diphtheria, tetanus, pertussis or poliomyelitis * known or suspected immune dysfunction * receipt of medications / vaccination that may interfere with study assessments * known true hypersensitivity to any of the vaccine components or to a vaccine containing the same substances * known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition * thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection * any medical condition that might interfere with the evaluation of the study objectives * febrile illness
single-cycle remote ischemic preconditioning and postconditioning (scrip) trial

Conditions: Ischemic Reperfusion Injury

Summary: this trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to evaluate efficacy and safety of remote ischemic preconditioning and postconditioning in patient undergoing coronary angioplasty.


Eligibility criteria:
inclusion criteria: * eligible for percutaneous coronary intervention (elective and emergency cases) * age \> 18-year-old * informed consent exclusion criteria: * previous cabg * previous pci in 1 week / treatment with thrombolysis within 30 days * peripheral arterial disease / a-v shunt of upper extremities (avf for hemodialysis) * paresis of upper limb * unstable patient such as cardiogenic shock / vasopressor / iabp / cooling (hypothermia) * fatal cardiac arrhythmia (vt / vf) * chronic hypoxia

Keywords: ischemic preconditioning postconditioning angioplasty
trehalose administration in subjects with spastic paraplegia 11 (3al-spg11)

Conditions: Hereditary Spastic Paraplegia; Spastic Paraplegia Type 11

Summary: hereditary spastic paraparesis type 11 (spg11) is caused by mutations in the spg11 gene that produces spatacsin, a protein involved in lysosomal function.

several experiments on subjects affected by neurodegenerative diseases with dysfunction of the autophagic-lysosomal system show that trehalose improves the pathological phenotype. this evidence indicates that trehalose could be used in patients with spg11 to try to prevent the accumulation of glycosphingolipids at the lysosomal level and induce the genesis of new lysosomes. this study aims to record clinical data of 20 patients with spg11 who take trehalose during 12 months.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of spg11 * written signed informed consent exclusion criteria: * diagnosis of other concomitant neurodegenerative diseases * taking other experimental drugs within 30 days of the first study visit (t0) and during the study * refusal to sign informed consent